Genotoxicity Studies of PolyGlycopleX (PGX) a novel dietary fiber

International Journal of Toxicology

Volumn 28, Issue 4, 2009, Pages 318-331

  Marone, Palma Ann ^a   Lyon, Michael ^b,c   Gahler, Roland ^d   Donath, Claudia ^e   Hofman Hüther, Hana ^e   Wood, Simon ^b  

^a Eurofins Medinet Inc   (Germany)

^b Canadian Centre for Functional Medicine   (Canada)

^c UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^d Factors R and D Technologies   (Canada)

^e BSL Bioservice Scientific Laboratories GmbH   (Germany)

Author keywords

Ames test; Dietary fiber; Genotoxicity; Mammalian erythrocyte micronucleus; PGX

Indexed keywords

POLYGLYCOPLEX; POLYSACCHARIDE; UNCLASSIFIED DRUG;

AMES TEST; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BACTERIAL STRAIN; CONTROLLED STUDY; DIETARY FIBER; ESCHERICHIA COLI; GENOTOXICITY; MALE; MICRONUCLEUS TEST; MOUSE; NONHUMAN; RAT; SALMONELLA TYPHIMURIUM;

ALGINATES; ANIMALS; BIOTRANSFORMATION; DIETARY FIBER; DRUG COMBINATIONS; ESCHERICHIA COLI; MICE; MUTAGENICITY TESTS; POLYSACCHARIDES, BACTERIAL; SALMONELLA TYPHIMURIUM;

ANIMALIA; BACTERIA (MICROORGANISMS); ESCHERICHIA COLI; MAMMALIA; MUS; SALMONELLA TYPHIMURIUM;

EID: 73149083074     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1177/1091581809338955     Document Type: Article

References (48)

1. Blackwood AD, Salter J, Dettmar PW, Chaplin MF. Dietary fibre, physicochemical properties and their relationship to health. J R Soc Prom Health. 2000;20: 242-247.
2. Jenkins DJA, Wolever TW, Leeds AR, et al. Dietary fibres, fibre analogues, and glucose tolerance: importance of viscosity. Br Med J. 1978;27:1392-1394.
3. Slavin JL. Position of the American Dietetic Association: health implications of dietary fiber. J Am Diet Assoc. 2008;108:1716-1731.
4. Dikeman CL, Fahey GC. Viscosity as related to dietary fiber: a review. Crit Rev Food Sci Nutr. 2006;46: 649-663.
5. Jenkins DJ, Kendall CW, Axelsen M, Augustin LS, Vuksan V. Viscous and nonviscous fibres, nonabsorbable and low glycemic index carbohydrates, blood lipids and coronary heart disease. Curr Opin Lipidol. 2000;11: 49-56.
6. Vulksan V, Jenkins DJA, Spadafora P, et al. Konjacmannan (glucomannan) improves glycemia and other associated risk factors for coronary heart disease in type 2 diabetes. Diabetes Care. 1999;22:913-919.
7. Nishinari K, Williams PA, Phillips GO. Review of the physico-chemical characteristics and properties of konjac mannan. Food Hydrocol. 1992;6:199-222.
8. Jenkins DJA, Jenkins MA, Wolever TMS, Taylor RH, Ghafari H. Slow release carbohydrate: mechanism of action of viscous fibers. J Clin Nutr Gastroenterol. 1986;1:237-241.
9. Brownlee IA, Allen A, Pearson JP, et al. Alginate as a source of dietary fiber. Crit Rev Food Sci Nutr. 2005;45:497-510.
10. Paxman JR, Richardson JC, Detterman PW, Corfe BM. Daily ingestion of alginate reduces energy intake in free-living subjects. Appetite. 2008;51:713-719.
11. Trout DL, Ryan RO, Bickard MC. The amount and distribution of water, dry matter, and sugars in the digestive tract of rats fed xanthan gum. Proc Soc Exp Biol Med. 1983;172:340-345.
12. Doi K, Matsuura M, Kawara A, Uenoyama R, Baba S. Effect of glaucomannan (konjac fiber) on glucose and lipid metabolism in normal and diabetic subjects: genetic environmental interactions. In: Melsh JS, Hanna J, Baba S, eds. Diabetes Mellitus: Proceedings of the Third Symposium on Diabetes Mellitus in Asia and Oceania. Amsterdam: Excerpta Medica; 1981: 306-312.
13. Inovobiologic Product Monograph. PGX (Polyglycoplex). Calgary, Canada: Canadian Center for Functional Medicine; 2006: 30190-r4.2.
14. World Health Organization. Toxicological Evaluation of Certain Food Additives and Contaminants: Twenty-First Report of the Joint Expert Committee on Food Additives. Geneva, Switzerland: World Health Organization; 1987. Technical Report Series Numbers 607-626.
15. World Health Organization. Toxicological Evaluation of Certain Food Additives and Naturally Occurring Toxicants: Thirtieth Report of the Joint Expert Committee on Food Additives. Geneva, Switzerland: World Health Organization; 1993. Technical Report Series Numbers 746-768.
16. World Health Organization. Toxicological Evaluation of Certain Food Additives and Contaminants: Thirty- Seventh Report of the Joint Expert Committee on Food Additives. Geneva, Switzerland: World Health Organization; 1996. Technical Report Series Numbers 864-872.
17. CFSAN. Correspondence from the Division of Petition Control, Center for Food Safety and Applied Nutrition (CFSAN) regarding GRAS Affirmation Petition No. 6G0418. Obtained through the Freedom of Information Act; 1995. 000872-000901.
18. U.S. Food and Drug Administration (FDA). Konjac candy recalls. FDA press releases/talk papers. http://www.fda.gov/oc/po/firmrecals/topics/konjac.html. Accessed March 10, 2009.
19. European Commission. Reports of the Scientific Committee for Food. Directorate-General Industry: Forty-First Series. Brussels, Belgium: European Commission; 1997:45-48.
20. Food and Drug Administration. Acute toxicity studies with konjac flour. WHO Food Additives Series 32. http://www.inchem.org/documents/jecfa/jecmono/ v32je10.htm. Accessed June 11, 2009.
21. Cifone MA, Bowers L. Mutagenicity test on konjac flour FW-KON in the L5178Y TK+/- mouse lymphoma forward mutation assay with a confirmatory assay. Unpublished study (FMC Report No. 195-1979) from Corning Hazleton, Vienna, Virginia. Submitted to WHO (World Health Organization) by FMC Corp, Princeton, NJ; 1995.
22. Murli H, Arriaga J. Mutagenicity test on konjac flour FW-KON in an in vivo micronucleus assay. Unpublished study (FMC No. 195-1980) from Corning Hazleton, Vienna, Virginia. Submitted to WHO (World Health Organization) by FMC Corp, Princeton, NJ; 1995.
23. Ishidate M, Sofuni T, Yoshikawa K, et al. Primary mutagenicity screening of food additives currently used in Japan. Food Chem Toxicol. 1984;22:623-636.
24. Astrup A. Dietary management of obesity. JPEN J Parenter Enteral Nutr. 2008;32:575-577.
25. Carabin IG, Lyon MR, Wood S, Pelletier X, Donazzolo Y, Burdock GA. Supplementation of the diet with the functional fiber PolyGlycoplex is well tolerated by healthy subjects in a clinical trial. Nutr J. 2009;8:9.
26. Vuksan V, Jenkins DJA, Spadafora P, et al. Konjacmannan (glucomannan) improves glycemia and other associated risk factors for coronary heart disease in type 2 diabetes. Diabetes Care. 1999;22:913-919.
27. Vuksan V, Rogovik A, Ezatagha A, et al. Viscosity of Dietary Fiber Determines Lipid Lowering Effects in Healthy Individuals. Toronto, Canada: University of Toronto; 2006.
28. Jenkins AL. Determination of Glycemic Index Lowering Potential of PGX in Liquid and Solid Food Formulations. Final report of Glycemic Index Laboratories for Inovo- Biologic Inc, Toronto, Canada; 2006.
29. Vuksan V, Panahi S, Lyon M, Rogovik AL, Jenkins AL, Leiter LA. Viscosity of fiber preloads affects food intake in adolescents. Nutr Metab Cardiovasc Dis. 2009 Jan 20. [Epub ahead of print].
30. Vuksan V, Sievenpiper JL, Owen R, Swilley JA, SpadaforaP, JenkinsDJA et al.Beneficial effects of viscous dietary fiber from konjac-mannan in subjects with insulin resistance syndrome. Diabetes Care. 2000;23:9-14.
31. Rogovik A, Jenkins A, Brietman P, Vuksan V. A blend of highly viscous polysaccharide decreases relative CVD risk in three population groups. Presentation of the Natural Health Products Research Program of Canada. 3rd Annual Conference, Toronto, Ontario, Canada, March 3, 2006.
32. Matulka RA, Lyon M, Wood S, Marone PA, Merkel DA, Burdock GA. The safety of PolyGlycopleX (PGX) as shown in a 90-day rodent feeding study. Nutr J. 2009;8:1-11.
33. Ames BN, Durston WE, Yamasaki E, Lee FD. Carcinogens are mutagens: a simple test system combining liver homogenates for activation and bacteria for detection. Proc Natl Acad Sci U S A. 1973;70:2281-2285.
34. Maron DE, Ames BN. Revised methods for the Salmonella mutagenicity test. Mut Res. 1983;113:173-215.
35. Ames BN, Lee FD, Durston WE. An improved bacterial test system for the detection and classification of mutagens and carcinogens. Proc Natl Acad Sci U S A. 1973;70:782-786.
36. Claxton LD, Allen J, Auletta A, Mortelmans K, Nestmann E, Zeiger E. Guide for the Salmonella typhimurium/ mammalian microsome tests for bacterial mutagenicity. Mut Res. 1987;189:83-91.
37. Kier LE, Brusick DJ, Auletta AE, et al. The Salmonella typhimurium/mammalian microsomal assay: a report of the U.S. Environmental Protection Agency Gene-Tox- Program. Mut Res. 1986;168:69-240.
38. Hayashi M, Tice RR, MacGregor JT, et al. In vivo rodent erythrocyte micronucleus assay. Mut Res. 1994; 312:293-304.
39. Heddle JA. A rapid in vivo test for chromosomal damage. Mut Res. 1973;18:187-190.
40. Dertinger SD, Torous DK, Tometsko KR. Simple and reliable enumeration of micronucleated reticulocytes with a single laser cytometer. Mut Res. 1996;37: 283-292.
41. Krauth J. Locally most powerful tied rank test in a Wilcoxon situation. Ann Math Stat. 1971;42:1949-1956.
42. Lovell DP. Statistical analysis of in vivo cytogenetic assays. In: Kirkland DJ, ed. Statistical Evaluation of Mutagenicity Test Data. Cambridge, UK: Cambridge University Press; 1989:184-230.
43. Schmitt D, Tran N, Riefler S, et al. Toxicologic evaluation of modified gum acacia: mutagenicity, acute and subchronic toxicity. Food Chem Toxicol. 2008;46: 1048-1054.
44. Yoon SJ, ChuDC, Juneja LR. Chemical and physical properties, safety and application of partially hydrolized guar gum as dietary fiber. Clin Biochem Nutr. 2008;42:1-7.
45. Brusik D. Mutagenic evaluation of compounds. Unpublished report from Litton Bionetics, Inc, submitted to the WHO by United States Food and Drug Administration; 1975.
46. Litton Bionetics. Summary of mutagenicity screening studies, contract FDA71-268, gum tragacanth hostmediated assay, cytogenetics, dominant lethal assay, L.B.I. Project No. 2311. Unpublished report of Litton Bionetics Inc. Submitted to WHO (World Health Organization) by U.S. Food and Drug Administration; 1972.
47. Litton Bionetics. Mutagenicity evaluation of gum tragacanth. LBI Project No. 20671. Unpublished report of Litton Bionetics Inc. Submitted to WHO (World Health Organization) by U.S. Food and Drug Administration; 1977.
48. Maxwell WA, Newell GW. Study of the mutagenic effects of FDA-71-114 (Locust bean gum). Unpublished report from the Stanford Research Institute submitted to WHO (World Health Organization) by Hercules BV; 1972.